A Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)

TerminatedOBSERVATIONAL
Enrollment

176

Participants

Timeline

Start Date

September 27, 2017

Primary Completion Date

February 15, 2019

Study Completion Date

February 28, 2019

Conditions
Breast Lesions
Interventions
DEVICE

Intact Breast Lesion Excision System (BLES)

Intact BLES is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. It is uniquely suited to maintain lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical procedure.

Trial Locations (7)

23320

The Breast Center at Chesapeake Regional Healthcare, Chesapeake

30058

Metro Surgical Associates Inc., Lithonia

30342

Winship Cancer Institute-Emory St. Joseph's, Atlanta

30720

Dalton Surgical Group, Dalton

35205

Birmingham Breast Care, Birmingham

37203

Nashville Breast Center, Nashville

01040

Holyoke Medical Center, Holyoke

All Listed Sponsors
lead

Medtronic Surgical Technologies

INDUSTRY